Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage.

Aaron Kesselheim and colleagues examine orphan-designated drugs approved between 2009 and 2015 in the United States.

Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study.

Context: The high cost of new prescription drugs and other medical products is a growing health policy issue. Many of the most transformative drugs and vaccines had their origins in public-sector funding to nonprofit research institutions. Although the Bayh-Dole Act of 1980 provides for "march-in rights" through which the government can invoke some degree of control over the patents protecting products developed from public funding to ensure public access to these medications, the applicability of this provision to current policy options is not clear.

Engineered bivalent ligands to bias ErbB receptor-mediated signaling and phenotypes.

The ErbB receptor family is dysregulated in many cancers, and its therapeutic manipulation by targeted antibodies and kinase inhibitors has resulted in effective chemotherapies. However, many malignancies remain refractory to current interventions. We describe a new approach that directs ErbB receptor interactions, resulting in biased signaling and phenotypes.